The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Condition	Intervention	Phase
Heart transplantation Cardiac transplantation Transplantation, Cardiac Transplantation, Heart Grafting, Heart	Drug: Tacrolimus	Phase III

Further Study Details: 

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients (or their legal guardians) who are capable of understanding, and who have been fully informed of, the purpose of the study and the risks of participation.
• Patients (or their legal guardians) who have signed and dated the Informed Consent form and are willing and able to follow the study protocol.
• Patients who are primary cadaveric heart transplant recipients.
• Males or females from birth.
• Female patients of child-bearing potential who have a current negative pregnancy test and agree to practice effective birth control, as judged by the investigator, while participating in the study. Prepubescent pediatric patients will not require pregnancy testing.
• Patients able to tolerate oral medication and who do not have a gastrointestinal condition likely to affect the absorption kinetics or metabolism of the oral study medications.

Exclusion Criteria:

• Previous organ transplant recipients.
• Multi-organ transplant recipients.
• Recipients of a heart from a donor with incompatible ABO blood type.
• Patients with significant graft dysfunction and/or significant de novo infection(s) at time of randomization
• Patients with known hypersensitivity to tacrolimus, cyclosporine, MMF, daclizumab, prednisone, cremophor, polysorbate 80 and/or HCO-60.
• Patients who are pregnant or lactating or planning to become pregnant prior to completion of the study.
• Patients who have consumed an investigational product in the 30 days prior to transplantation or at any time during post-transplantation follow-up.
• Patients receiving cholestyramine or colestipol.

• Patients having any one of the following at enrolment:

  1. History of malignancy, not chart-documented as cured or active malignancy (with exception of eradicable non-metastatic in-situ basal cell or squamous cell carcinoma).
  2. Leukopenia (white cell count < 2500/cu mm).
  3. Anemia (hemoglobin < 80 g/L).
  4. Positive test for Hepatitis B surface antigen and/or Hepatitis C.
  5. Historical positive test for Human Immunodeficiency Virus (HIV).
  6. Serum creatinine > 230 umol/l.
  7. Continual elevation of AST and/or ALT to >= 3X the upper limit of normal.
  8. Body mass index (weight in kg / height in m2) > 30.
• Undiagnosed diabetes mellitus as determined by 2h OGTT or fasting glucose test or uncontrolled diabetes mellitus at screening. In either case, the patient may be declared as no longer excluded by this criterion upon establishment of control of the diabetes through appropriate medical management.
• Blood glucose >= 11.1 mmol/L at pre-operative assessment.
• Patients having a significant disease, substance dependency, or disability that may prevent adherence to, or understanding of, the protocol and/or the investigator’s instructions.

Please refer to this study by ClinicalTrials.gov identifier  NCT00157014

Astellas Pharma Canada, Inc Medical Information      1-888-338-1824 

California
      Los Angeles,  California,  90095,  United States; Recruiting
Canada, Alberta
      Calgary,  Alberta,  T2N 2T9,  Canada; Recruiting
      Edmonton,  Alberta,  T6G 2B7,  Canada; Recruiting
      Edmonton,  Alberta,  T6G 2 J3,  Canada; Not yet recruiting
Canada, British Columbia
      Vancouver,  British Columbia,  V6Z 1Y6,  Canada; Recruiting
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 3A7,  Canada; Recruiting
Canada, Ontario
      Ottawa,  Ontario,  K1Y 4W7,  Canada; Recruiting
      London,  Ontario,  N6A 5A5,  Canada; Recruiting
      Toronto,  Ontario,  M5G 2N2,  Canada; Recruiting
      Toronto,  Ontario,  M5G 1X8,  Canada; Not yet recruiting
Canada, Quebec
      Sainte-Foy,  Quebec,  G1V 4G5,  Canada; Recruiting
      Montreal,  Quebec,  H1T 1C8,  Canada; Recruiting
      Montreal,  Quebec,  H3A 1A1,  Canada; Recruiting

Study chairs or principal investigators

Medical Monitor,  Study Director,  Astellas Pharma Canada, Inc.   

Study ID Numbers:  FKC-009
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157014
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13